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NCT06492616 · ClinicalTrials.gov registry record · Phase 3
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
A Phase 3 study of Breast Cancer, sponsored by Stemline Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 4,220
- Enrollment target
- 20
- Study locations
NCT06492616 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Stemline Therapeutics. The registered enrollment target is 4,220 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT06492616, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Stemline Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 4,220 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Elacestrant
Study Locations (20)
California
- Comprehensive Blood & Cancer Center - Bakersfield
- UCSF Cancer Center Berkeley - Berkeley
- City of Hope National Medical Center - Duarte
- UCSF Wash Cancer CNTR - Fremont
- UC San Diego Moores Cancer Center - La Jolla
- Helios Clinical Research - Long Beach
- Cancer and Blood Research Center, LLC - Los Alamitos
- USC/Norris Comprehensive Cancer Center - Los Angeles
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UC Irvine Health, Chao Family Comprehensive Cancer Center - Orange
- Stanford Women's Cancer Center - Palo Alto
- Dignity Health dba Health Research Institute - Sacramento
Arizona
- Ironwood Cancer and Research Centers - Chandler
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Scottsdale
- Arizona Clinical Research Center, Inc. - Tucson
- University of Arizona Cancer Center - Tucson
Alabama
- Southern Cancer Center, PC - Daphne
Arkansas
- Highlands Oncology Group, PA - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,220 participants |
| Start Date | 2024-09-27 |
| Est. Completion | 2032-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06492616
The ClinicalTrials.gov registry entry for NCT06492616 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 4,220 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (51% higher). The listed sponsor is Stemline Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Tamoxifen is the first listed.
NCT06492616 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06492616 about?
NCT06492616 is a clinical study titled "A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence". The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
What is the current status of trial NCT06492616?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,220 participants. The study started on 2024-09-27. Estimated completion is 2032-10.
What conditions does trial NCT06492616 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06492616?
The interventions under investigation include: Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Elacestrant (DRUG).
Who is sponsoring clinical trial NCT06492616?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06492616 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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